Ginger, ext.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Ginger, ext.

EC Number:

283-634-2

EC Name:

Ginger, ext.

Cas Number:

84696-15-1

Molecular formula:

N/A

IUPAC Name:

Essential oil extract of Zingiber officinalis (Zingiberaceae) root GINGER ESSENTIAL OIL Ginger Oil Ginger Oleoresin Ginger, ext Ginger, ext. Ginger, Extrakt HE Zingiber officinalis INCI name: Zingiber Officinale (Ginger) Root Extract OILS, GINGER Reaction mass of camphene and pin-2(3)-ene and 7-methyl-3-methyleneocta-1,6-diene and pin-2(10)-ene and cineole and [S-(R*,S*)]-5-(1,5-dimethylhexen-4-yl)-2-methyl-1,3-cyclohexa-1,3-diene and (R)-p-mentha-1,8-diene Zingiber officinalis, Zingiberaceae.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

skin obtained from plastic surgery from multiple donors

Details on animal used as source of test system:

The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.

Vehicle:

unchanged (no vehicle)

Control samples:

not required

Test animals

Species:

other: human skin model EpiDermTM

Strain:

other: no

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Observation period:

23 hours 25 minutes

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 1.412

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item Ginger, ext. is considered as non-irritant to skin.
After the treatment, the mean value of relative tissue viability was reduced to 87.5%. This value is above the threshold for skin irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).
For these reasons, the result of the test is considered valid.